Cleared Traditional

K933908 - MEDRAD CT CUSTOM CONVENIENCE KIT

K933908 is an FDA 510(k) clearance for MEDRAD CT CUSTOM CONVENIENCE KIT, manufactured by Medrad, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K933908 · Medrad, Inc. · Cardiovascular device
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Feb 1994
Decision
198d
Days
Class 2
Risk

K933908 is an FDA 510(k) clearance for the MEDRAD CT CUSTOM CONVENIENCE KIT. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Medrad, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 198 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medrad, Inc. devices

FDA 510(k) Submission Details - K933908

510(k) Number K933908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1993
Decision Date February 25, 1994
Days to Decision 198 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 125d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 169
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K933908.
MEDRAD SPECTRIS MR INJECTOR
K935668 · Medrad, Inc. · Sep 1995
SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT
K951802 · Scimed Life Systems, Inc. · Jul 1995
MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE
K934086 · Medrad, Inc. · Jun 1995
CAVERNOSOMETRY MODULE FOR MENUET
K923117 · Dantec Medical, Inc. · Feb 1993
MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD
K924116 · Medrad, Inc. · Jan 1993
MEDRAD MCT-PLUS INJECTOR
K913624 · Medrad, Inc. · Jul 1992